Overpressure Safety Valve - Japan LH130JRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00699753450233), received between Jul 30, 2018 and Oct 19, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K820297); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OUT OF BOX, A DUCKBILL VALVE WAS DEFECTIVE. THIS WAS IDENTIFIED DURING INSPECTION AT THE FACTORY. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7985867 ↗
• MalfunctionSep 5, 2018Suction Failure; Suction Failure

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE SAFETY VALVE WAS UNABLE TO SUCTION. THE VALVE WAS REMOVED AND THE PROCEDURE WAS CONTINUED WITHOUT USING THE VALVE. *NO CONSEQUENCE TO PATIENT, *PRODUCT WAS NOT CHANGED OUT , *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844829 ↗
• MalfunctionSep 4, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OUT OF BOX, A DUCKBILL VALVE WAS DEFECTIVE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7844344 ↗
• MalfunctionAug 21, 2018Suction Failure; Suction Failure

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING SETUP, THE VALVE WAS UNABLE TO SUCTION. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 7803840 ↗
• MalfunctionJul 30, 2018Obstruction of Flow; Obstruction of Flow

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE DUCKBILL VALVE WAS UNABLE TO SUCTION. THERE WAS BLOOD LOSS OF APPROXIMATELY 5 ML. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss

  MAUDE report 7732862 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K820297. One submission often covers many models, so check the product and lot details in each record.

• Z-0256-2018 · Jun 27, 2017 · Terminated
  TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
• Z-0257-2018 · Jun 27, 2017 · Terminated
  Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369
• Z-1828-2015 · May 6, 2015 · Terminated
  Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed
• Z-0603-2014 · Jun 4, 2013 · Terminated
  Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line